Let the patient participate in drug-safety reporting, NEJM commentary says

There's an interesting "Perspective" on drug-safety reporting in the March 11 issue of The New England Journal of Medicine. The article, by Dr. Evan Baugh of Mount Sinai Hospital in New York, notes that when a patient wants to know about symptoms related to a prescription drug he is taking, he might consult the information on the label or in the package insert. However, this information on side effects is based mostly on clinical trials and clinicians' impressions of their patients' symptoms, rather than on the firsthand reports of patients taking the drug. Yet,a substantial body of evidence contradicts the assumption that this information is truly representative of the patient experience. Instead, Baugh says, research indicates that clinicians systematically downgrade the severity of patients' symptoms, that patients' self-reports frequently report side effects that clinicians miss, and that clinicians' failure to note these symptoms results in the occurrence of preventable adverse effects. Patient self-reporting offers one solution that would enhance the capture of subjective elements of safety information. Baugh believes patient-reported adverse events provide both clinical and scientific value and arutes that patients are entitled to know the impressions of their peers. Scientist, regulators, and clinicians should have access to patient impressions when evaluating drugs, Baugh says. He also suggests that administrative efficiency might actually improve if patients reported adverse events before clinical interactions. Self-reports, Baugh concludes, are more sensitive to underlying changes in patients' functional status than are clinicians' reports. The patient is more likely to identify symptoms earlier during a course of treatment. It seems like a common sense approach to drug-safety reporting.